23 November 2021 - - US-based software-based medicines developer Pear Therapeutics, Inc has received Breakthrough Device Designation from the US Food and Drug Administration for its reSET-A PDT product candidate designed for the treatment of alcohol use disorder, the company said.

reSET-A potentially expands Pear's addiction franchise, which includes FDA-authorized products to treat substance use disorder and opioid use disorder.

This is the second such Breakthrough Device Designation received by Pear, following the designation awarded for reSET-O, the first ever for a PDT, which was for the treatment of OUD.

Alcohol is one of the most commonly used substances in the United States. AUD is a clinical diagnosis of alcoholism, or alcohol addiction characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences.

According to a national survey, approximately 14m adults ages 18 and older in the US had AUD in 2019 with fewer than one in 10 individuals with a 12-month diagnosis of AUD receiving any treatment.

Each year, an estimated 95,000 people die from alcohol-related causes, making alcohol the third-leading preventable cause of death in the United States4 with an estimated total annual medical cost in hospitals of USD 7.6bn.

Today, there are few treatment options for patients with AUD with less than 2% of patients with AUD receiving medication for treating AUD6. In the US TODAY, there are no FDA-authorized medical devices or PDTs indicated for people suffering from AUD-only.

The Breakthrough Devices Program is intended for devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The program is designed to expedite development of the device and the prioritized review of the subsequent regulatory submissions, although there is no assurance that any of these benefits may be experienced.

It is available for devices, like PDTs, which may be subject to FDA review under a premarket approval application, premarket notification (510(k)), or De Novo classification request.

Pear's AUD-only PDT product candidate, reSET-A, has not received marketing authorization from FDA and is not available for sale in the United States.

Prescription Digital Therapeutics are a new therapeutic class that uses software to directly treat disease.

Like traditional medicines, PDTs are developed in a GMP-compliant environment, tested in randomized controlled trials demonstrating safety and effectiveness, evaluated and authorized by regulators like FDA, and used under the supervision of a prescribing clinician.

Unlike traditional medicines, PDTs are designed to collect real world data for use by prescribing clinicians and for population health management by payors and health systems.

Pear Therapeutics is a leader in prescription digital therapeutics, or PDTs. Pear aims to redefine medicine by discovering, developing, and delivering clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers.

Pear has a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from the FDA.

Pear's lead product, reSET, for the treatment of substance use disorder, was the first PDT to receive marketing authorization from FDA to treat disease.

Pear's second product, reSET-O, for the treatment of opioid use disorder, was the first PDT to receive Breakthrough Designation.

Pear's third product, Somryst, for the treatment of chronic insomnia, was the first PDT submitted through FDA's traditional 510(k) pathway while simultaneously reviewed through FDA's Software Precertification Pilot Program.

reSET-O is intended to increase retention of patients with Opioid Use Disorder in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only prescription digital therapeutic.